1. Field of the Invention
The present invention relates to the field of laxatives and laxative-based treatments. More particularly, the present invention relates to promoting overnight laxation and control of bowel function in individuals who are otherwise prone to constipation.
2. Background Information
Constipation is a syndrome (a collection of symptoms) that includes the inability to have a bowel movement in a regular fashion, excess flatus or intestinal gas that exists as trapped bubbles that cause feelings of pain, bloating and cramping in the abdominal area. Constipation is the most common gastrointestinal complaint in the United States. Over 4,000,000 people (approximately 2% of the population) have frequent constipation as determined by self-assessment surveys.
Current treatments of constipation fall into two main categories, each with distinct disadvantages. One category, which includes the cathartics or purgatives and the osmotic agents, causes a bowel movement to occur generally within a few hours, in an uncontrollable fashion. That is, a patient who takes a purgative or cathartic laxative has an obligatory bowel movement within minutes to a few hours. The patient is unable to ignore the sensation of urgency, and risks soiling of their garments or gastrointestinal distress from the sense of urgency if they so attempt. The bowel movement due to a cathartic or purgative laxative is characterized by unpredictability and urgency in the patients so that the patients"" control of when or where the bowel movement occurs is virtually nonexistent. Examples of these laxatives are bisacodyl, senna, lactulose, saline laxatives and GI lavages.
A second category of laxatives, made up of so-called bulk formers, is composed of digestible or indigestible polymers of carbohydrates and other materials chemically synthesized or appearing in nature, such as psyllium and methylcellulose. While the bulk formers do not produce a sense of uncontrollable urgency, the time course of their efficacy is longer in duration than the cathartics or purgatives. The bulk formers do not produce a bowel movement for as long as two to three days. While the sense of urgency is therefore diminished, the relief is delayed. A more ideal means of treating constipation combines the short time course of efficacy of the purgatives with the lack of uncontrollable urgency that accompanies the bulk formers. Such a product produces overnight relief without urgency, and allows the patient to more readily control the time and place of their bowel movement, providing unique relief to their constipation syndrome.